If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Flomaxtra Side Effects Reported to FDA

The following Flomaxtra reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

The appearance of Flomaxtra on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

Laceration, Contusion, Blood Urine Present, Rash

This is a report of a 62-year-old male patient (weight: NA) from AUSTRALIA, suffering from the following symptoms/conditions: prostatic disorder,nocturia, who was treated with Flomaxtra (dosage: NA, start time: Jun 01, 2011), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:

Laceration

Contusion

Blood Urine Present

Rash

which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Flomaxtra treatment in male patients, resulting in laceration side effect.

Constipation, Myocardial Infarction

This report suggests a potential Flomaxtra Xl (tamsulosin) Orodispersable Constipation, Myocardial Infarction side effect(s) that can have serious consequences. A 76-year-old male patient (weight: NA) from was diagnosed with the following symptoms/conditions: NA and used Flomaxtra Xl (tamsulosin) Orodispersable (dosage: 400 Ug, Uid/qd) starting Oct 05, 2010. Soon after starting Flomaxtra Xl (tamsulosin) Orodispersable the patient began experiencing various side effects, including:

Constipation

Myocardial Infarction

Drugs used concurrently:

Paracetamol

Fish Oil

Although Flomaxtra Xl (tamsulosin) Orodispersable demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as constipation, may still occur.

This Perineal Induration, Priapism, Retrograde Ejaculation, Spontaneous Penile Erection problem was reported by a physician from . A 53-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: urinary tract disorder. On Oct 24, 2007 this consumer started treatment with Flomaxtra Xl (tamsulosin) Orodispersable (dosage: 400 Mcg). The following drugs were being taken at the same time:

Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as perineal induration, may become evident only after a product is in use by the general population.

This is a report of a male patient (weight: NA) from UNITED KINGDOM. The patient developed the following symptoms/conditions: benign prostatic hyperplasia and was treated with Flomaxtra Xl (tamsulosin) Orodispersable Cr Tablet 0.4mg (dosage: NA) starting Feb 19, 2007. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:

Fatigue

Malaise

Micturition Disorder

Migraine

Palpitations

Tachycardia

This opens a possibility that Flomaxtra Xl (tamsulosin) Orodispersable Cr Tablet 0.4mg treatment could cause the above reactions, including fatigue, and some male subjects may be more susceptible.

Concurrently used drugs: NA. This finding indicates that some male patients could be more vulnerable to Flomaxtra Xl (tamsulosin) Orodispersable Cr Tablet 0.4mg.

Dizziness, Gait Disturbance, Insomnia

A 88-year-old male patient from UNITED KINGDOM (weight: NA) experienced symptoms, such as: urinary tract disorder and was treated with Flomaxtra Xl (tamsulosin) Orodispersable Cr Tablet 0.4mg(dosage: NA). The treatment was initiated on Jan 01, 2006. After that a consumer reported the following side effect(s):

Dizziness

Gait Disturbance

Insomnia

Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Flomaxtra Xl (tamsulosin) Orodispersable Cr Tablet 0.4mg efficacy: NA.

Dyspepsia, Headache, Toothache, Urinary Incontinence

In this report, Flomaxtra Xl (tamsulosin) Orodispersable Cr Tablet 0.4mg was administered for the following condition: bladder obstruction.A male consumer from UNITED KINGDOM (weight: NA) started Flomaxtra Xl (tamsulosin) Orodispersable Cr Tablet 0.4mg treatment (dosage: NA) on Apr 17, 2007.Sometime after starting the treatment, the patient complained of the following side effect(s):

Dyspepsia

Headache

Toothache

Urinary Incontinence

A possible interaction with other drugs could have contributed to this reaction:

Zoton

Calcichew

Kolanticon

Paracetamol

Actonel

Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Flomaxtra Xl (tamsulosin) Orodispersable Cr Tablet 0.4mg treatment could be related to the listed above side effect(s).

Top 10 Flomaxtra Side Effects for Women

Women Side Effects

Reports

Top 10 Flomaxtra Side Effects for Men

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

You can use them to remind you of details that may alert your health care professional(s) to a problem

You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

Log Form

You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

Medicine Name and Dosage:

Side Effects

Scale

Date & Time

Other Medicine(s) or Treatment(s)

Scale: 1 = very mild to 10 = very bad

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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